Acquired Bleeding Disorder, Bleeding During/Following Surgery
Conditions
Brief summary
This trial is conducted in Europe, North America and Oceania. The aim of this trial is to evaluate the haemostatic efficacy of activated recombinant human factor VII in subjects undergoing orthotopic liver transplantation surgery.
Interventions
DRUGactivated recombinant human factor VII
120 mcg/kg into the vein (i.v.) bolus injection first administered immediately prior to first skin cut. Repeated every two hours until approx. 30 minutes prior to expected start of the reperfusion of the transplanted liver. 120 mcg/kg single bolus administration at completion of wound closure
DRUGplacebo
Trial drug into the vein (i.v.) bolus injection first administered immediately prior to first skin cut. Repeated every two hours until approx. 30 minutes prior to expected start of the reperfusion of the transplanted liver. Single bolus administration at completion of wound closure
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Scheduled to undergo orthotopic liver transplantation * Liver disease classified as Child-Turcotte (Pughs modification) score B or C
Exclusion criteria
* Previous liver transplantation * Scheduled multi-organ transplantation * Scheduled for living related donor transplantation * Present renal insufficiency requiring dialysis * Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total number of RBC units transfused during the perioperative period | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of RBC units transfused by surgical phase | — |
| Adverse events | — |
| Changes in coagulation related parameters | — |
Countries
Australia, Canada, France, Germany, Spain, Sweden, United Kingdom
Outcome results
None listed